# K250328: UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Apr 30, 2025 after 84 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K935595 (1995). 131 ancestors in all.
No later device cites it as a predicate yet.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121076: Ultraextend FX, Ultrasound Workstation Package, Toshiba America Medical Systems, In.C (2012) Summary page 6.

## Indications for use
UltrabExtend NX CUW-UO01S Ultrasound Image Analysis Program is designed to allow the user to observe images and perform analysis based on examination data acquired using the following diagnostic ultrasound systems; TUS-AI900, TUS-AI800, and TUS-AI700. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

Source page: https://510kreport.com/device/K250328
Methodology: https://510kreport.com/methodology